Exam 2 PPT Slides - New Drug Development & FDA Communications

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Exam 2 PPT Slides - New Drug Development & FDA Communications
Kevin Vu
Quiz by Kevin Vu, updated more than 1 year ago
Kevin Vu
Created by Kevin Vu over 8 years ago
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Resource summary

Question 1

Question
Select the statements that pertain to Pre-IND (Investigational New Drug) that takes places in Phase 0.
Answer
  • Reach agreement on animal studies required to initiate human studies
  • Discuss scope & design for Phase 1 and pediatric studies
  • Format of IND dossier
  • Generally reserved for severely debilitating and life-threatening illness with accelerated approval program

Question 2

Question
The FDA has three types of meeting: - Type A meeting: to help an otherwise stalled development program - Type B meeting: pre-IND, end-of Phase 1, end-of Phase 2, pre-Phase 3, pre-Biologics License Application (BLA) - Type C: occurs within 75 days of FDA receipt of request
Answer
  • True
  • False

Question 3

Question
Orphan drug: to treat rare medical conditions (orphan disease), affecting fewer than 300,000 patients in USA, may be sold without competition for seven years, National Organization of Rare Diseases (NORD) & European Organization for Rare Diseases (EURORDIS)
Answer
  • True
  • False

Question 4

Question
Drug labeling includes:
Answer
  • A. All printed information accompanying a drug, label, wrapping & package insert
  • B. FDA Division of Marketing, Advertising & Communication seeks balanced, not misleading, scientifically accurate information for health care practitioners
  • C. Label claim (indication) is particularly important to sponsor because of its connection to reimbursement
  • D. A & B only
  • E. A and C only
  • All the above

Question 5

Question
2016 Prescription Drug User Fee Agreement (PDUFA): ‘application fees for an application requiring clinical data ($________), for an application not requiring clinical data or a supplement requiring clinical data ($________)
Answer
  • $2,374,200 (requiring clinical data); $1,187,100 (not requiring clinical data)
  • $2,374,200(not requiring clinical data); $1,187,100(requiring clinical data)
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